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Without fanfare, GlaxoSmithKline (GSK) quietly announced today that the US Food and Drug Administration (FDA) granted approval for CERVARIX® [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant] for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 for use in girls and young women (aged 10-25).

It has taken GSK over three years to garner US regulatory approval for CERVARIX® which has been approved and used in over 100 other countries in the world. Early "unspecified concerns" delayed approval and, as recently as two weeks, FDA delayed a decision despite recommendations from an advisory panel to approve the vaccine. Coincidentally, a week before the agency was expected to announce approval for the vaccine, a British girl died after she was vaccinated with Cervarix. While FDA spokespersons claimed that the girl’s death following vaccination had nothing to do with the delaying a decision on Cervarix, many industry pundits believe that the FDA was reluctant to approve the vaccine in light of the sensational media coverage in the UK surrounding the incident. After an autopsy was performed on the girl, British authorities announced that a massive cardiac tumor that had infiltrated one of her lungs, not Cervarix was responsible for her death.

Today’s approval of Cervarix provides American consumers with an alterative to Gardasil, Merck’s cervical cancer vaccine that was approved about two years ago. That said, the ability to protect girls and young women from the possibility of developing cervical cancer is more important than which of the two vaccines is used to induce immunity. I plan on immunizing my daughter when she is old enough!

Until next time...

Good Luck and Good Job Hunting!!!!!!!

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The U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that clinical data support both the efficacy and safety of Cervarix®, GlaxoSmithKline (GSK) cervical cancer vaccine.

In a press release, the company announced that “Cervarix was shown to be highly effective and well tolerated in girls and young women for the prevention of cervical pre-cancers and cervical cancer related to human papillomavirus (HPV) types 16 and 18, the two most common virus types that cause cervical cancer. The committee also discussed data demonstrating the efficacy of  Cervarix against additional cancer-causing virus types.”

The Committee’s favorable recommendation, although not binding, will be considered by the FDA in its final review of the Biologics License Application (BLA) for the candidate vaccine.

In March 2009, GSK submitted final data from its Phase III pivotal study (HPV-008), the single largest efficacy trial of a cervical cancer vaccine to date. The file included data from clinical trials in more than 30 countries involving nearly 30,000 participants receiving Cervarix, which reflect an ethnically and racially diverse population and a broad range of women. It also included a thorough safety assessment relevant to 10-25 year old girls and young women.

Cervarix® has been approved in nearly 100 countries around the world, including the 27 member states of the European Union (EU), Australia, Brazil, South Korea, Mexico and Taiwan. Licensing applications have been submitted in more than 20 additional countries, including Japan and the United States. GSK also received World Health Organization (WHO) prequalification in July 2009.

The likely approval will provide girls and women with an alternative to Merck’s cervical cancer vaccine Gardasil which has been on the market for almost two years. Gardasil has recently come under fire by religious and anti-vaccine groups and sales have been lackluster lately. It will be interesting what effect if any Cervarix will have on the US anti-HPV/cervical cancer market. That said, I doubt whether Merck executives will be sleeping as well as they have been prior to today’s advisory panel recommendation!

For a great comparison of the two vaccines check out an article in today's New York Time business section.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!

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The Eye on FDA blog reported today that AstraZeneca and Sanofi-Aventis have joined the ranks of Abbott, GSK, J&J and SanofiPasteur on YouTube. Pharmaceutical companies are taking advantage of the power of YouTube and other social media sites because regulatory guidance hasn’t been issued on its use to promote products or brand awareness. In other words, this is uncharted territory and companies can essentially 'test the waters' to see how far regulatory agencies will let them go.  I suspect that early life sciences company adopters of social media will garner substantial ROI before regulatory guidance is issued.

A lack of regulatory oversight, the ability to manage and control content and the low costs associated with creating Internet videos make YouTube and other social media sites attractive to pharmaceutical and biotechnology companies. The life sciences sector is just beginning to recognize the power of social media and the role that it may play in promoting products and brand awareness to consumers.  Expect many more life sciences companies to experiment with social media in the near future--its a veritable goldmine!

Until next time…

Good Luck and Good Video Watching!!!!!!! 

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About a year ago, I was eating lunch and bunch of pharma executives were at the table next to me. I inadvertently overhead bits of their conversation and I heard the words, Facebook, MySpace and YouTube mentioned. This suggested to me that pharma was more aware of social media (and its business implications) than pharma publicly cared to admit. Pharma has been reluctant to embrace social media because of possible legal and regulatory ramifications. Nevertheless, a few companies have decided to boldly go where no pharma company has gone before—to YouTube.

The Eye on FDA blog, which is very bullish on social media, has been keeping aof pharma companies that have created channels on YouTube, the video site owned by Google. To date, Sanofi Pasteur, GSK, Abbot and JNJ have taken the YouTube plunge (see SanofiPasteurTV , GSKVision, AbbottChannel, andJNJHealth).  I suspect that pharma companies are willing to take a risk on YouTube, because unlike other social media platforms, they can disable the functionality that allows viewer to leave comments, kudos or kvetches after viewing videos. This shields the companies from unwarranted claims, misinformation about its products and negative publicity.

At present, the US Food and Drug Administration, has issued little or no guidance on the use of social media by drug makers. This means that drug makers are in uncharted territory and can experiment with social media without fear of much regulatory oversight or scrutiny.  Now that pharma has broken the social media barrier, I wonder whether MySpace, Facebook and Twitter (the hottest new social media tool at the moment) will be next. Interestingly, I learned yesterday that Novartis uses twitter and can be followed @Novartis.

Off the record conversations with MySpace representatives suggest that a number of pharmaceuticals have quietly created branded product pages on MySpace for years.  As the MySpace rep put it, how can you ignore an audience of 60 million people?  Further, Facebook’s fan pages are growing in popularity and don’t be surprise to see pharma pages begin to appear there. It will be interesting to see how pharma will incorporate social media into its business and marketing models in the future.

Until next time…

Good Luck and Good Video Watching!!!!!!!!

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The Pharmalot blog reported yesterday that GlaxoSmithKline (GSK) will tell its US pharma employees today about a new reorganization plan that will include more job cuts. The restructuring will primarily affect sales reps and some R&D personnel. GSK, like most other pharma companies, has been steadily downsizing operations and headcount for the past year or so at its US locations in Research Triangle Park, NC and Philadelphia PA

Look for the layoffs to occur before Thanksgiving—just about the time when employee’s annual bonuses are calculated.

Until next time…

Good Luck and Good Job Hunting!!!!!!!!

P.S.  It was learned today by the Phamalot Blog that 1,880 sales reps and sales support staff job will be eliminated over the next few months. Also, the company may consolidate its Philadelphia and Research Triangle Park headquarters.

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The Centers for Disease Control and Prevention said about 25% of teenage girls received at least one dose of Merck & Co.'s Gardasil vaccine in 2007, providing the first national estimate of usage of the company’s controversial anti- HPV (cervical cancer) vaccine.

A 25% usage rate for a a new vaccine during its first year on the market is outstanding. That said, Merck’s Gardasil is the only approved anti-HPV vaccine in the US. Approval of GlaxoSmithKline’s competing product, Cervarix, by FDA has been delayed for so-called “regulatory issues.” Also, Merck has been heavily promoting Gardasil use via well-crafted DTC ads and a variety of clever promotional campaigns aimed at adolescent girls and their mothers.

Despite all the negative press and Merck’s questionable marketing practices, Gardasil appears to be doing very well—something that Merck desperately needs.

Until next time…

Good Luck and Good Job Hunting!!!!!!!

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The recent bad press about Gardasil, Merck’s anti-cervical cancer vaccine, must have been keeping its marketing and advertising executives up at night because the company recently launched a marketing campaign called Charm4Life—a line of jewelry designed to raise awareness about cervical cancer. According to a post at the Pharmalot Blog, women (or concerned men) can pay $32 for any of four “limited edition” bangles designed by Carolyn Rafaelian, a designer with Alex and Ani.  The Charm4Life campaign could also be in response to the likely approval early next year of Cervarix, GlaxoSmithKline’s anti-HPV vaccine.

Merck insists that the campaign is to promote awareness about cervical cancer and that all proceeds from sale of the bangles will go to the Prevent Cancer Foundation. Of course, the real goal of the campaign is to promote Gardasil vaccination by raising their awareness of cervical cancer.  

The $32 price tag for the bangles is way cheaper than the $365 it costs for the Gardasil vaccination series. That said, I hope women don’t buy the bangles and forego Gardasil vaccination.

Hat tip to Ed at Pharmalot

Until next time…

Good Luck and Good Job Hunting!!!!!!!

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It was only a matter of time after J & J launched its health channel on YouTube two weeks ago, that other pharma companies would begin to post videos on video-sharing sites. As a general rule, nobody in pharma wants to be first but after the first company takes the plunge, nobody wants to be left out or behind. Therefore, it came as no surprise when late last week, GlaxoSmithKline (which has a tendency to be second-to-market with competing products), launched a beta version of it so-called GSKCIC channel on You\Tube.

 According to a post on the Pharmalot blog, so far there are only two videos on the channel. One describes the company ongoing commitment and fight against disease in the developing world (ironically, the video ends prematurely).The second, which is full length, features CEO Andrew Witty telling us about his career at GSK (which began in 1985 as a management trainee) and how GSK is looking for a few good employees who “like a good challenge.” Curiously, the day after the Witty video appeared on YouTube, GSK announced that it was laying off about 90 workers or 10% of its work force at its manufacturing plant in Zebulon, North Carolina. A company spokesperson said that more cuts are expected at the North Carolina facility.

Maybe someone at GSK ought to tell its CEO that the company isn’t hiring at the moment?????????

Hat tip to Ed at Pharmalot!

Until next time….

Good Luck and Good Job Hunting!!!!

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The old adage “When it rains, it pours” is particular apt for the bad news that has plagued the once venerable Merck & Co for the past five years. First, there was the Vioxx scandal, followed in short order by the Vytorin and Singulair messes and now it appears that the company’s new anti-cervical cancer vaccine, Gardasil, may have —pardon the expression — a few “warts” on it. 

Last night on my local nightly news, there was a brief report about emerging safety issues with Gardasil. According to the report, adverse events ranging from “massive wart outbreaks to seizures and paralysis” have been reported for the anti-HPV vaccine. Since its approval in 2006, over 8,000 adverse event reports (the total number of people vaccinated was not disclosed) and 18 alleged deaths have been reported for Gardasil (although none of the deaths has been directly linked to Gardasil vaccination). This news comes on the heels of a recent Wall Street analyst’s report indicating that sales of Gardasil are much lower than expected. It appears that the vaccine, once considered by Merck insiders as the new blockbuster that could save the flagging drug maker, may, after all, be relegated to specialty drug status.

As many of you may know, GlaxoSmithKline (GSK) is seeking US approval for its anti-cervical cancer vaccine called Cervarix. Although Merck beat GSK to market, Cervarix has undergone more clinical testing and allegedly may have a better safety and tolerability profile than Gardasil (only the regulatory agencies know for sure). Nevertheless, it is not clear whether GSK will benefit or be injured by the negative publicity that Gardasil is receiving. As I mentioned in a previous post, the US Food and Drug Administration (FDA) recently delayed Cervarix’s approval pending submission of additional data that the agency requested from GSK.

Before anybody puts a nail in Gardasil’s coffin, it is important to point out who started the recent firestorm about the vaccine. It was none other than the conservative-funded public interest group Judicial Watch. It is no secret that this group advocates abstinence over condom usage and other methods to prevent sexually transmitted diseases. Further,  I suspect that a majority of Judicial Watch’s members don’t believe sex education or pre-marital sex for that matter. Finally, I have no doubt that Judicial Watch received some support (financial, spiritual or otherwise) from the anti-vaccination lobby that is unfortunately gaining strength in the US and elsewhere.

From a scientific standpoint, it is difficult to get a real measure of the safety of a vaccine until it has been widely used by large numbers of people. Although pivotal Phase III trials are required for all vaccine approvals, the number of people studied in these trials (sometimes in the tens of thousands) is not sufficient to predict all possible safety problems that may emerge when the vaccine gains widespread use. For this reason, regulatory agencies typically require vaccine manufacturers to conduct mandatory post marketing Phase IV clinical trials that are designed to address the seriousness of any possible safety concerns that may have emerged after a vaccine has been on the market for several years. Because all vaccine makers know this, it is still not clear to me why Merck, a company which has been in the vaccine business for a very long time, embarked on its failed lobbying campaign to get Gardasil on the mandatory US vaccination schedule shortly after it was approved. 

As I have said in the past, ALL pharmaceutical and biotechnology drugs have side effects and their occurrence and severity varies from person to person. Generally speaking, most drugs are approved by regulatory agencies because their potential benefits outweigh real or presumed safety risks. That said, the question facing all parents who have daughters is: Does protection against cervical cancer outweigh any adverse events or potential safety risks associated with Gardasil or Cervarix vaccination? It is a tough question but one that my wife and I and others will have to answer for our daughters!

Until next time…

Good Luck and Good Job Hunting (avoid Whitehouse Station, NJ)!!!!!!!!!

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